Note: this report was based on the information I had available at the time.

Report for the IEE Healthcare Technologies Professional Networks  Executive

 Regarding the proposal for state Registration of ‘Clinical Technologists’ as being petitioned to the Health Professions Council (HPC) by the Institute of Physics and Engineering in Medicine (IPEM)

 Kevin R. Haylett, PhD,C.Eng.,MIEE

Contract and IT Manager

Principal Clinical Scientist / Honorary Research Fellow

Central Manchester and Manchester Children’s Hospitals University Trust

Medical Engineering

Manchester Royal Infirmary

Oxford Road

Manchester

M13 9WL

 

Tel:0161 276 4539

Fax:0161 276:4514

 web: http://www.medeng.net

email: kevin.haylett@cmmc.nhs.uk

 

INDEX

1 Background.
2 June 2004 – Awareness of registration.
3 July 2004 – Survey of northern EBME (Medical Engineering) departments 
4 July 2004 – First letter to HPC and DoH.
5 July – Second Letter to HPC and DoH.
6 October – Third Letter to DoH.
7 November – Contacted by DoH by email.
8 December / January – contacted my MP.
9 Conclusion.
10 Appendices.
10.1 Briefing document for Brian Iddon MP
10.2 Final Response from Doh by email
10.3 Second Letter to HPC and DoH
10.4 First questions to DoH and HPC regarding state registration of ‘Clinical Technologists’
10.5 Results of IPEM Voluntary Register of Clinical Technologists
 

1         Background

 In 2004 the Institute of Physics and Engineering in Medicine (IPEM) petitioned the Health Professions Council (HPC) for the state registration of a group of workers they describe as ‘Clinical Technologists’. This group includes a wide range of workers who play a technical role within the NHS. These range from users of technology to those that maintain, repair and service medical equipment and devices. As a senior manager for one of the largest medical engineering groups within the northwest, this registration has a potential to make a huge impact on the services we provide. I have, to date, not seen any consultation regarding this proposed registration of my staff.

 As a result I have tried to engage both the Health Professions Council and the Department of Health I have asked many detailed questions over the course of the previous year which have had little answers or response. These range from questions about appropriate consultation with the appropriate institutions such as the IEE, Unions, commercial sector etc to the financial impact this registration will have on the NHS. 

 The following report identifies by timeline my enquiries and includes some of the letters to and from the DoH.

 Fundamentally, I feel that IPEM are not in a position to represent the workers involved without the support of the IEE and trade unions. IPEM were originally called the Hospital Physicists Association (HPA). In 1992 they changed their name to Institute of Physics and Science in Medicine (IPSM) and in the mid nineties they changed the name to the Institute of Physics and Engineering in Medicine (IPEM). It my opinion that they have neither the engineering experience nor credentials to represent workers in engineering in the NHS and commercial sector regarding medical devices and this it is vital that those Institutions, such as the IEE who have the required experience in this role, are involved.

2         June 2004 – Awareness of registration

  I became aware from a colleague involved in registration of a different group of workers (GI Physiologists) that IPEM had petitioned the HPC to regulate ‘Clinical Technologists’.

 I confirmed this on IPEMs web site. They had set up a voluntary register and apparently had a ballot ( see appendix  10.5 for details  - only 51% (775 people) had voted of which only a proportion were staff maintaining and servicing medical devices).

 Main points: 

bulletNone of my departments staff were members of IPEM.
bulletNone of my departments staff were on the voluntary register
bulletNo Information had been received from the DoH or the Strategic Health Authorities or our Trust executive
bulletNo information had been received by unions representing our staff
bulletOf 35 staff, two are members of IEE and the rest are represented by UNISON

 I was extremely concerned that there had been no consultation, I was aware of, with the wider medical engineering community. IPEM seemed to be going alone and have been given de facto the authority by the DoH to carry the process through on behalf of all staff concerned in both the NHS and commercial sector. I had a large number of questions that I felt needed answering.

3         July 2004 – Survey of northern EBME (Medical Engineering) departments

 I attended a meeting of the Northern EBME Benchmarking Group. This is a group of heads of departments and senior members of EBME Departments in the North of England who benchmark and compare services.

 Main points

 From a show of hands  

bulletOnly two of approximately 20 members were members of IPEM
bulletMost admitted that their staff were not on the voluntary register
bulletNone had been involved in any consultation

4         July 2004 – First letter to HPC and DoH 

I wrote a series of questions regarding the Registration of ‘Clinical Technologists’ to the chairman of the Health Professions Council (Mr M Searle). A copy of the questions is enclosed. It highlighted a number of important points:

bulletIEE not involved or consulted
bulletUnions not involved or consulted
bulletCommercial sector not consulted (The same services are provided by the commercial sector)
bulletDTI not consulted
bulletResult of survey of benchmarking Group
bulletIPEM do not represent all the staff or groups concerned

 I received a response with no detailed answers. I was told that these were mainly questions for the DoH. However, they did send me a copy of the rules for placing new groups petitioning for registration. I had a great concern as the DoH appear to have little knowledge or understanding of the engineering professions as they are mainly focussed on the traditional healthcare professions. 

5         July – Second Letter to HPC and DoH 

After reading the rules regarding petitioning groups I asked the HPC  questions directly about the petition made by the IPEM in the hope of getting some detailed answers. Again I received little response to the questions raised. However, the HPC did promise to send a  copy of IPEMs petion. I have still not received a copy (January 2005). 

6         October – Third Letter to DoH 

I sent a new letter with copies of previous letters requesting that my points be seriously considered and highlighting that I had not had any responses and that many important questions had not been answered or even discussed. 

7         November – Contacted by DoH by email

Although I still no written response to the many questions raised I was contacted by DoH and invited to a meeting (London 26th November) to discuss the petition. Sadly, I was given only two weeks notice and could not attend (I was having surgery). I asked for my questions to be raised at the meeting and pointed out, that even if I could attend, I would not be able to represent all the interested parties or stakeholders.

 Outcome of meeting

bulletRegistration to proceed and include medical engineering staff
bulletQualification to be Honours Degree in Clinical Technology
bulletNone of my questions were asked or raised at the meeting (see enclosed DoH email)
bulletIPEM posted that the result of the meeting on their website and stated that all stakeholders had been consulted
bulletOnly one hour was given in the meeting for all consultation

 Following a request to the DoH by email I was given a list of attendees. I also asked for a copy of the meetings minutes.

 Main points

bulletThe only Union being represented was AMICUS. However, most staff are members of UNISON
bulletOnly one head of a medical engineering department was present
bulletI was told the IEE was being represented by members of AIME a group of whom I had no prior knowledge.  I contacted the IEE’s policy unit who had no knowledge of AIME representing them in such discussions. I emailed the DoH to explain this, but to date I have had no response.
bulletThe main members of the meeting were members of IPEM or the Association of Renal Technologists (ART). A small group of technical workers employed in renal dialysis.
bulletThe DoH would not give me a copy of the minutes

Notes regarding requirement for honours degree in Clinical Technology: 

bulletNo such Degree exists
bulletMost Medical Engineering/EBME/ Medical Electronics staff employ vocationally qualified  staff with HNC/HNDs. Where staff do have degrees they are primarily electronic and electrical engineering. This new approach would involves a major shift in qualification
bulletThis previous vocational model has proved to be successful.

8         December / January – contacted my MP

I had a meeting with my MP (Dr Brian Iddon - 15th Jan) who said he would write to John Reid (Secretary of State for Health) and flag this issue.

9         Conclusion 

Enclosed is a briefing document I wrote for Dr Brian Iddon my MP. It includes many of the questions that I feel need addressing.

To date I have received no answers to most of the important and serous questions I have raised. It is my opinion there has been inadequate consultation regarding this issue. I feel the process of registration of this profession is being taken forward to the next stage (public consultation) by the HPC before the necessary consultation with the relevant unions and institutions has taken place.

I would like and feel that the IEE should be involved with this process.  I feel that if AIME does not represent the IEE regarding these registration and standards (they certainly do not represent me!) then a letter should be sent by the IEE to the DoH (Chief Scientific Officer) making this clear. As an IEE member I would like the IEE to represent me and to get involved in this matter so that any final registration can be made to work.

In my opinion it is important, that should registration take place, it is applied not only to NHS workers but also to those in the commercial sector. Otherwise, the NHS will be in an untenable position that unqualified and unregistered engineering staff could work within the NHS if they are employed by external contractors from the commercial sector, but NHS staff must be registered. In practice this should not be possible as occupations regulated by the HPC apply both to the commercial and NHS sector. In this case I am unclear why the commercial sector has not been consulted.  There is a need for a comprehensive study to examine the impact this registration will have on both the financial and quality of medical engineering services. Also the current engineering and quality standards and registration schemes need examining to see how this new proposed registration scheme will fit in. 

Finally, I would like to se a review by the IEE of the medical engineering profession within the NHS. It my feeling there is a glass ceiling presented by these departments often included as parts of wider medical physics departments and that the most senior positions are more often held by staff with a physics based background. I feel this is maybe part of the reason that medical engineering has a very low profile in the UK when compared with other countries such a the USA.

Kevin R. Haylett, PhD,C.Eng.,MIEE                        26/01/2005

 

10   Appendices

Enclosed 

10.1 Briefing document for Brian Iddon MP
10.2 Final Response from Doh by email
10.3 Second Letter to HPC and DoH
10.4 First questions to DoH and HPC regarding state registration of ‘Clinical Technologists’
10.5 Results of IPEM Voluntary Register of Clinical Technologists
 

10.1          Briefing document for Brian Iddon MP

 (Note not all references included as paper copies)  

 Perceived problems with the current process  of the state registration of Clinical Technologists

 Enclosed: communications with the DoH and the Health Professions Council (HPC) [1-5].

 Background - The Institute of Physics and Engineering (IPEM) placed a petition with the HPC to regulate a body of healthcare workers described as ‘Clinical Technologists’. Following a recent meeting this appears to be progressing with the DoH and the HPC [5].

 My concern is for those staff included in this definition whose job is the installation, maintenance, servicing and repair and development of medical devices. I represent one of the largest Medical Engineering Departments in the North West at the Central Manchester and Manchester Children’s University Hospitals NHS Trust. Importantly, in practice we directly compete as an in house organisation with commercial companies providing the same services.

 Similar NHS Trust departments have a wide range of descriptions including, Medical Engineering, Clinical Engineering, EBME (Electronics and Bio-Medical Engineering), Medical Electronics, Medical Physics, Medical Equipment Maintenance Organisation and more!

 The jobs involved in medical equipment maintenance are carried out by staff in both the NHS and the private sector which is a multibillion pound part of the economy. Most NHS Trusts have this work carried out by internal departments and also by staff employed under service contracts provided by the private sector.

 The registration of these staff has many consequences regarding, staff recruitment, training and education and cost to the NHS and private sector to name just a few. 

 I have brought these issues to the Head of my Department (one of the largest Medical Engineering Departments in the North West) to find that he has never been officially informed of the future possibility of registration of medical engineering staff. There has been no contact or information regarding registration of these staff from Executive Management, Strategic Health Authorities, Human Resources or from any other routes such as Trade Unions or professional bodies such as the Institute of Electrical Engineers (IEE) or IPEM.

 Main Issues

 Lack of transparency – I have been unable to get a copy of IPEM petition and this has not been presented for national debate. In my opinion the process of deciding and consulting about the requirement for registration of the staff concerned has not been carried out in a reasonable and transparent manner.

 No response to questions - There has been little room for questions and feedback into the process from interested parties such as myself. Despite forwarding numerous questions to both the HPC and the Chief Scientist of the NHS I have been unable to get a detailed response to any of my questions. These are enclosed [1, 2, 3]. I am certain that industrial sector is unaware of the impact of this regulation may have on their staff.

 NHS / Commercial sector conflict - For all previous groups of staff, regulation by the HPC has meant that all similar workers in both the NHS and private sector are regulated e.g. physiotherapists, podiatrists etc. In this case I would have expected the consultative exercise to also include stakeholders from the private sector. Professionally, I would also have expected at least an impact study that this regulation will have on the NHS and the commercial sector. If the intent is for only NHS staff to face regulation while not regulating commercial companies doing the same job, then this would seriously impact upon the ability of NHS departments to compete with the commercial sector. The regulation of NHS staff will impose considerable costs which the commercial sector would not have to bare.

 Insufficient evidence to base decisions - I am not sure that the DoH even has a list of all the Medical Engineering departments within the UK and knows the number of staff this registration will affect in both the NHS and the private sector. I have requested this type of information but none has been forthcoming. I would have also expected consultation with the heads of at least the large departments that run these services within the NHS and to determine what percentage of these staff are represented by IPEM.

 Staff representation - It is my professional opinion that IPEM do not represent a large group of workers that are included in IPEMs definition of Clinical Technologists.  I am a Chartered Engineer and Member of the Institute of Electrical Engineers. This organisation has not been consulted. I am unaware that IPEM represent any members of the industrial sector. For example within the northern EBME Benchmarking group only 2 of approximately 20 heads of departments were members of IPEM and  most stated that there staff were not members.

 Commercial interests - I would also have expected consultation with the Department of Trade and Industry regarding the implications of regulating these staff in the commercial sector. There are already many regulations and standards that relate to medical devices. This is a highly regulated area with international regulations.  However, there appears to have been no study on the effect this new regulation is going to have on both the commercial sector and the NHS in terms of economic effect and impact on recruitment within staff in the NHS and the commercial sector.

 Inadequate consultation with stakeholders -  To date there has been only one meeting for one hour arranged by the DoH, arranged at very short notice to discuss these issues with IPEM and the ‘stakeholders’ [4]. Although invited, as a result of the short notice I was unable to attend. However, I did ask for specific questions to be raised. I have unable to obtain the minutes or a list of those ‘stakeholders’ who attended [4] to find out whether my questions were raised or what was actually discussed. From this single meeting alone it was decided to proceed with the process of registration [5]. Surprisingly, it was also determined that the future minimum qualification for these staff would be an Honours Degree, apparently because of a technical problem in auditing vocational qualifications like the HNC/D [5]. Note: It is not unusual to have staff in the private sector to have little formal qualifications. In the Medical Engineering Department at Central Manchester the qualifications usually requested and found to be most suitable are vocational qualifications such as an HNC/D combined with in house training. It is my professional opinion that this single meeting that constituted the consultation with the stakeholders has been insufficient and a more formal and complete process is required.

 Cost to the NHS – What is the estimated cost to the NHS of implementing this new regulation? Currently benchmarking of in house maintenance shows savings of 30% over manufacturers suppliers costs for maintenance. Across the NHS this probably accounts to many tens of millions. Regulation of only NHS staff and not those from the commercial sector may erode this saving by incurring considerable additional training costs.

 IN CONCLUSION - Although understanding the political drive to regulate all healthcare workers I am concerned that the process of state registration for the staff involved in the maintenance of medical equipment has not been considered clearly and the consultation with stakeholders has been inadequate. The main argument apparently presented by IPEM is that these workers have potential to affect the health of patients (although I have not been able to see the petition). However, I am unaware of any evidence that has been presented to support that there is a problem with the current position. I feel that the route to safety regarding medical equipment maintenance is the adoption of externally auditable international quality standards such as those used within industry. Many medical equipment maintenance departments have invested heavily in registration to the ISO9000 quality system which includes all the elements of assessing competency of staff etc. Why have these routes not been investigated? What is the evidence for the need for registration? Where is the national debate? Where are the impact studies regarding registration? Why can I not get answers to my questions? What is the projected cost of registration to the NHS? Why has there been no formal process of consultation with the stakeholders? Why is IPEM petitioning for registration of these staff? Why has the IEE, the Institute responsible for standards in Electrical Equipment not appeared to have been consulted? What is the requirement and need for these staff to be regulated? Why is implementation of the current international quality standards, which also apply to companies not sufficient?

 I have enclosed a list and details of my communication with the DoH (Chief Scientist) and HPC (Chief executive and registrar) which included a number of detailed questions to which I have had little response (see 1,2,3). In practice these are only the first questions that come to mind and believe that a wider consultation must take place before this process goes much further. I am also concerned at IPEM driving this process of regulation forward. IPEM have a vested interested and have been using this process as a recruitment drive for their society. It would appear a small number of unelected IPEM members and associates have both set up and dominated the voluntary register for clinical technologists and are directing an agenda that may have an impact on thousands of healthcare staff with no mandate. Although the petition may be based upon good intent it may introduce considerable problems for both the NHS and the commercial sector.

 

10.2          Final Response from DoH by email

 

Recent response from DoH to questions regarding meeting of 26th November

 The lines in italics are from the DoH. The rest is my original email.

  

Kevin

 Thank you for your e mail regarding the meeting held on 26th November to discuss the regulation of clinical engineers by the Health Professions Council. I have taken the opportunity of responding to you within the body of your original e mail which I have reproduced below. I hope this is acceptable.

Professional Standards and Pensions

Project Manager

2N35B

Quarry House

0113 254 5787

 

Dear 'Project Manager',

 

I am extremely concerned at the details published on the IPEM web site about the State Registration of 'Clinical Technologists'.

 The details published on the IPEM website are a matter for IPEM. As you see below I have attached copies of presentations that were given at the meeting.

 To date I have sent numerous letters to Professor Sue Hill regarding this process. I have forwarded many questions and put considerable effort into trying to put some feedback into this process.  However, I have still had no answers regarding any of the questions raised. Sadly, I could not attend the meeting, due to its arrangement at such short notice, held to discuss this matter.

 It appears that some serious decisions have been made without any answer to many of my questions.

 I can confirm to you that the questions you posed were not asked of the meeting in that manner but the issues which you raised in your correspondence were covered by Professor Hill, the Chief Scientific Officer (CSO), and other attendees at the meeting. I can assure you that we are grateful for the time you have taken in representing your views in relation to this matter. The meeting had a robust discussion about the level and type of education best suited to the future of this group of technologists, taking into account issues around recruitment, retention and career progression. The consensus was that the development of a vocational Honours degree was the way forward, with a multiplicity of entry and exit routes recognising that a number of individuals come into the NHS from other labour markets and need to access top up education and training that is subject to external independently assesses and quality assured programmes. An honours degree route would also provide a DipHE stepping off point for those individuals who could be working at associate practitioner levels who we also hope to regulate in the not too distant future. This together with the postgraduate level of registration associated with clinical scientists working in equipment management would eventually provide 3 primary levels of regulation.

 Whilst I and Professor Hill appreciate the points you make about the workforce they need to be looked at in the wider context of patient safety.You will appreciate that the  aim of statutory regulation is to protect the public as far as possible against the risk of poor practice. It is with this important aim in mind that a decision has been taken to progress the application of VRCT towards statutory regulation for clinical technologists, including the clinical engineering professions, who in the important work they undertake do unfortunately have the opportunity to cause harm to patients.

 The publication from IPEM stated that Unions were represented. I would me most grateful for a full list of those attending. In particular who represented the Institute of Electrical Engineering and their members? I would also like to know who represented the companies and the Department of Trade and Industry who carry out the majority of this work within the UK? As stated in my many letters IPEM do not represent a large number of Medical Engineering staff.

 The list of those invited included:

Not shown due to Data Protection Act: for information contact DoH

 Those who attended were:

Not shown due to Data Protection Act: for information contact DoH

 The President of AIME represented the constituent members of AIME who are:

                  The Institution of Chemical Engineers (IChemE)

                  The Institution of Electrical Engineers (IEE)

                  The Institute of Healthcare Engineering and Estate

                  Management (IHEEM)

                  The Institution of Incorporated Engineers (IIE)

                  The Institute of Materials, Minerals and Mining (IoM3)

                  The Institute of Physics (IoP)

                  The Institution of Mechanical Engineers (IMechE)

                  The Institute of Physics and Engineering in Medicine

                  (IPEM)

       AIME is chaired by each Institution in turn for a period of one year.

      The current Chairman (from May 2004) is (see AIME web site) (IHEEM)

 This statement published by IPEM would indicate that all those in the commercial sector carrying out the same job as those in the NHS will now have to have a degree in Clinical Technology. I feel this better than the dual approach previously considered, however, this would not only affect the hundred or so places required as discussed but would also effect thousands of workers in the UK commercial sector.

 Those clinical technologists working in the private sector undertaking the same functions and calling themselves by the same protected title would be required to also be regulated by the Health Professions Council. This is the same for all regulated professions whether they practice in the public sector or in private practice, e.g. physiotherapists. You will already be aware that it is Government policy that anyone working for or on behalf of the NHS should be of the same standard as a direct employee of the NHS, including, where necessary, being regulated.

 It must be clear that the jobs and service provided by Medical Engineering Departments is no different to that provided by suppliers of those services provided from Manufacturers and Suppliers of Medical Devices.

 Professor Sue Hill is intending to contact and discuss these matters with stakeholders from the private sector and other Government Departments in the New Year. I can assure you that she is fully aware of your concerns and you will recall did offer, albeit at short notice, to meet you when she was last in Manchester.

 I would be most grateful if you would forward this email and comments to Sue Hill. I would also be grateful if you could forward me minutes of the meeting and the responses to the questions that I asked to be raised.

 I will be sending out action points only from that meeting.

 Also, if this is the route that is to be finally taken, it must be disseminated through the correct professional NHS channels i.e. through the NHS Trust system so that the information can be forward to Human Resources Departments etc so that we are in a position of being able to plan for the future. There are already considerable problems recruiting staff and the outcome of this process may present further hurdles despite its good intent. I would also be grateful to be forwarded the details of any impact study this would have on recruitment and retention of Medical Engineering staff within the NHS.

 The information regarding the future regulation of clinical technologists will be communicated to all stakeholders through the means of a public consultation document and will include the Chief Executives of all NHS Trusts. This process will last for three months and will result in debates in both the Scottish and English Parliaments before a register is opened by the Health Professions Council. We also communicate information such as this in regular meetings with healthcare science leads in Workforce Directorates of most SHAs in England ( through a CSO/HCS SHA leads group) and at healthcare science policy meetings (and other CSO meetings) with Wales, Scotland and Northern Ireland

 I attach for your information copies of  presentations given at the meeting by myself, Darryn Kerr of NHS Estates who outlined developments around a career pathway for modern apprentices in engineering and Jim Methven of the VRCT. I hope this is helpful.

 (See attached file: DH Clinical Technologists 26 November 2004 JM.ppt)(See attached file: CSO mtg 26-11-04 DK.ppt)(See attached file: Engineers 26 November 2004 V2.ppt)

- - Disclaimer - -

This e-mail and any files transmitted with it are confidential. If you are not the intended recipient, any reading, printing, storage, disclosure, copying or any other action taken in respect of this e-mail is prohibited and may be unlawful. If you are not the intended recipient, please notify the sender immediately by using the reply function and then permanently delete what you have received.

 Incoming and outgoing e-mail messages are routinely monitored for compliance with the Department of Health's policy on the use of electronic communications. For more information on the Department of Health's e-mail policy click here http://www.dh.gov.uk/terms


 

10.3          Second Letter to HPC and DoH

 

Facilities Directorate

Department of Medical Engineering and Maintenance

Manchester Royal Infirmary

Oxford Road; Manchester

M13 9WL

 

 

Tel: 0161 276 4539

Fax: 0161 276 4514

Email: kevin.haylett@cmmc.nhs.uk

27/07/2004

 

    Contract and IT Manager

Dr K. R. Haylett,  PhD,C.Eng,MIEE

Mark Seale

Chief Executive and Registrar

HPC - Health Professions Council

Park House

184 Kennington Park Road

London

SE11 4BU

 

CC: Professor S.H. Hill – NHS, Chief Scientific Officer / Professor Norma Brook – President HPC

 

 Dear Mr Seale,

 I thank you for responding to my letter, dated 1st July, which included a number of questions regarding the possible State Registration of ‘Clinical Technologists’. Your letter, dated 12th July, and the accompanying guidance notes ‘Guidance for occupations considering applying for regulation by the Health Professions Council’ helped clarify the ongoing process of State Registration of ‘Clinical Technologists’.

 

However, I was disappointed to find that the questions raised are not to be addressed by the HPC as I feel they directly relate to the first parts of the process (A and B), as  outlined in the guidance notes i.e. the decision of  the HPC to refer to the DoH the case for State Registration of ‘Clinical Technologists’. I was surprised that the decision to progress was being taken further without these questions being initially addressed.

 1)         Could you please explain how the questions I originally raised will be addressed to the DoH. Will they be presented at an appropriate committee, meeting etc? If so which one? How and when will I receive the answers or response?

 Regarding Part A of the guidance notes

 I am unclear which occupation is being assessed and how these questions relate to the many occupations that are covered by the catch all phrase ‘Clinical Technologist’.

 2)         Could you please send the definition of Clinical Technologists and the occupation (jobs) that have been identified as belonging to this group?

  

Regarding Part B of the guidance notes

 Part B Question 1:  Each occupation wishing to be regulated will be required to: Cover a discrete area of activity displaying some homogeneity

 The term ‘Clinical Technologists’ covers a wide range of occupations (jobs). There is little homogeneity between staff carrying out maintenance and repairs of medical equipment and those technologists supporting Nuclear Medicine or those providing technological support in an Intensive Therapy or Neonatal Unit, or the many other occupations that are encompassed by the phrase ‘Clinical Technologist’.

Any decision to go further probably needs to identify the occupations in a clear and easily understood manner. What are the occupations (or jobs) that have been identified?

Part B Question 2:  Each occupation wishing to be regulated will be required to: Apply a defined body of knowledge

Without clearly identifying the occupations it is not possible to identify the body of related body of knowledge.

3)         How has the body of knowledge been identified for ‘Clinical Technologists’?

 Part B Question 4: Each occupation wishing to be regulated will be required to have at least one established body which accounts for a significant proportion of that occupations group

 Although the IPEM has some members involved in the maintenance and repair of medical equipment within the NHS, I do not feel that they represent the interests of the Medical Device industry i.e. those companies not only responsible for the manufacture design but also the maintenance and repair of medical devices.

 

3)         Could you please let me have the details of the evidence presented by IPEM that they represent 25% of those individuals who are employed within NHS and the private sector in the same occupation (maintenance and repair of medical devices)?

 As I understand the concept of State Registration, if this includes staff involved in the maintenance and repair of medical equipment, this would affect not only NHS staff but also the many thousands of employees who work for commercial companies who repair and maintain medical devices within the NHS. As I understand these companies would have to have staff who are State Registered to be eligible to maintain and repair equipment in the NHS. The range of companies is immense ranging from those that maintain and repair wheelchairs or walking sticks to those producing the most complex imaging systems.

 4)         How many of these commercial companies are aware of the current voluntary register and the impact of State Registration on their staff whose occupation is the maintenance and repair of medical devices?

 I feel that these questions need investigating and answering prior to recommendation being made to the DoH. With many commercial companies now providing third party equipment management, maintenance and repairs services within the NHS it is unlikely to be possible to differentiate between commercial companies providing maintenance and repair services and in-house departments providing the same service.

 Regarding the purpose of State Registration for those in staff involved in the maintenance and repair of medical equipment:

 In practice there has been a well established route to ensure quality and safe provision of medical equipment management, maintenance and repair services. I am unaware that there has been any evidence presented to the DoH that these systems have not been successful. These systems include the European legal framework of international standards (British, European and International), CE marking, the Medical Device Directive, the European quality standard ISO9001, and the NHS MHRA. The ISO9001 quality standard includes external and internal audit and elements such as staff training, competency etc.  In addition the NHS Controls Assurance now provides a framework for delivering and assessing performance of Medical Device Management including maintenance and repair which is being run in parallel with local and national benchmarking groups.

 If these systems have proven to be unsuccessful then, surely, the failure should be examined prior to some new system of State Registration for the members of staff that belong to the occupations involved in the management, maintenance, and repair of medical devices. A new layer of bureaucracy which would affect not only the NHS but also impact upon innumerable commercial medical device technology companies who employ staff in the occupations that provide these services.

 

5)         Has there been any evidence presented that the current systems to ensure the safe management; maintenance and repair of medical devices have been unsuccessful?

  

6)         The Medical Device Industry is estimated to contribute billions to the British economy. Has the Department of Trade and Industry been contacted and the impact assessed on the British economy that that State Registration may have on the Medical Device Industry?

 In conclusion, I would be most grateful for a detailed response regarding the questions raised within this letter and those outlined previously. I would like to take this opportunity to thank you for considering these points and am sure you will understand the importance of these questions, not only to my own organisation but also to the whole Medical Device Industry, a sector that contributes considerably to both the NHS and the British economy.

 

Yours sincerely,

 

 Kevin R. Haylett, PhD,C.Eng,MIEE                               (HPC Reg. No. – CS03597)

  

10.4          First questions to DoH and HPC regarding state registration of ‘Clinical Technologists’

 Concerns and questions regarding the process of State Registration of ‘Clinical Technologists’.  Dr K. R. Haylett 01/07/2004

 Following a recent meeting of the Northern Medical Engineering Benchmarking Group organised by the National Performance Advisory Group and discussion with the local UNISON branch. I have a number of serious concerns and questions regarding the process of State Registration of ‘Clinical Technologists’.

 State Registration appears to have been proposed by the organisation known as the Institute of Physics and Engineering in Medicine (IPEM), formerly the Hospital Physicists Association.

 A petition and vote of members of the IPEM’s voluntary register, for the case for State Registration of ‘Clinical Technologists’, has been presented. See attached details from the IPEM web site.

 Although in favour of State Registration for staff involved in the maintenance and servicing of medical devices (Medical Engineers, Clinical Technologists, Clinical Engineers and other titles) I am concerned about the case and process as it is has been presented to the DOH/HPC by the IPEM.

 The divide

 Historically, Medical Engineering services fall under two quite different management systems. One, Estates (Facilities Departments) and the other hospital Medical Physics Departments.

 Traditionally, those Medical Engineering services under Medical Physics Departments have been staffed by more vocationally trained staff and headed by Physicists/Clinical Scientists with a more academic based background.

 Whereas Facilities or Estates Departments have been staffed and headed by Engineers with an engineering and vocational background.

 In practice this means that staff based under Facilities or Estates Departments often have no relation to and even have a mistrust of the IPEM organisation as, historically, it has better represented it’s more academic members. This is evidenced by the relatively recent inclusion of an incorporated level of membership to allow those with staff with vocational qualifications to join with a different title. Staff representation in Estates based organisations is usually provided by MSF or UNISON or the Institute of Electrical Engineers (IEE). Also and importantly many equipment management, maintenance and services provided to the NHS are provided by the commercial sector.

 My main concerns regarding the process of State Registration of ‘Clinical Technologists’ follow:

  

1.         IPEM do not represent a large number of NHS staff and the many thousands of commercial service suppliers that the State Registration of ‘Clinical Technologists’ as proposed would have an impact on and these staff have not been consulted.

 In my own Department only 2 out of 30 staff members were on the IPEM voluntary register therefore had the opportunity to take part in the vote.

 On a show of hands, only 4-5 of the 25 managers and senior members of staff in the Northern Medical Engineering benchmarking group knew about the petition or had members of staff on the IPEM voluntary register.

 Of those on the IPEM’s Voluntary Register of Clinical Technologists only 51% voted (details attached). The term ‘Clinical Technologists’ as used by IPEM includes those staff managing, maintaining and servicing medical devices together with a wide range of other staff carrying out technical positions. It is unclear how many of these 51% are involved in medical equipment management, maintenance and servicing.

 Main questions

 1.1 What is the total number of staff in the NHS and the commercial sector involved in medical device management, maintenance and servicing that the State Registration process would impact upon?

 1.2 How many members of these staff are represented by IPEM?

 1.3 How many members of the staff voting in the IPEM ballot are involved in the management maintenance and servicing of medical devices?

 1.3 Importantly, why have the Heads of Medical Engineering Departments not been consulted through the normal NHS management structures that exist?

 

2.         In many organisations there is a distrust of IPEM by staff who feel that they preferentially represent IPEM’s more academic members.

 Due to the distrust of IPEM from many non Medical Physics based Medical Engineering Departments I feel that this organisation may not be the best to progress State Registration of ‘Clinical Technologists’ involved in the management, maintenance and servicing of medical equipment. I myself am concerned that this may be only a process to ensure increased membership and secure a controlling influence of the IPEM.

 It is my own opinion that the voluntary register should be managed by an NHS body or body agreed with the Unions (UNISON, MSF etc), the IEE (Institute of Electrical Engineers) and the IPEM due to the distrust of many members of non Medical Physics based Departments of the IPEM.

 

Main questions

 2.1 Is the IPEM the only organisation involved in bringing State Registration for Clinical Technologists?

 2.2 Have the Unions or other professional organisations such as the Institute of Electrical Engineers (This body is responsible for the standards regarding medical equipment) been consulted? If not, why not? If so would you forward details of any communications etc. State Registration has a potential to have major impact on their members including, training, career development wages and many other issues.

 2.3 The phrase ‘Clinical Technologist’ is vague and confusing, is there a definitive list of which jobs are described as ‘Clinical Technologists’?

 2.4 The use of the term ‘Clinical Technologist’s covers a wide group of staff with quite different responsibilities what consideration and consultation has gone into confirm this is the appropriate level for registration?

 2.5 Should those staff involved in the management maintenance and servicing of medical devices be better described and State Registered Medical Engineers or as Electro Biomedical Engineers (EBME) as more usually referred to?

 2.6 Would it be possible to have a Voluntary Register administered by the NHS to avoid problems with distrust of the IPEM from non IPEM represented staff? If not what other alternatives have been considered?

 

3.         There appears to be no ‘big picture’ of how medical device maintenance services are provided in the NHS and how many members of staff are employed by non Medical Physics based Departments.

 There needs to be survey of how Medical Engineering services are provided and how members of staff are being represented. I myself am a Chartered Engineer and Member of the Institute of Electrical Engineers. An Institute by Royal Charter unlike the ‘Institute of Physics and Engineering in Medicine’.

 If there is to be a representative vote, surely it must include all members of staff affected.

 Main questions

 3.1 Would you please supply a breakdown and details of how many staff are employed within the NHS involved in the Maintenance of Medical Devices and how the staff are distributed within Estates and Medical Physics Departments.

 3.2 Would you please let me know how these members of staff are being represented to the DoH and the HPC?

  

4.         There are deep and wide implications to providers within the commercial sector

 I am concerned at the implications for commercial providers of Medical Device Maintenance Services. Many Trusts have a wide range of devices serviced and maintained by external commercial providers rather than in-house departments. The commercial interests of these service providers need to be represented. If State Registration goes ahead for the NHS staff working on patient related medical devices, would the same State Registration be required for external providers? If not this may influence the market and methods of service provision i.e. NHS may incur additional training expenses when compared to external suppliers.

Main questions

4.1 What efforts have been made to consult with commercial service providers regarding State Registration?

4.2 Will the staff from commercial service suppliers have to meet the same criteria?

4.3 Would it be realistic to impose complex state registration of NHS service providers that would not be required by commercial suppliers? What are the issues involved?

 

5. There is a need for a clear and transparent process.

Presently this process of setting up State Registration for ‘Clinical Technologists’ is not clear with a wide numbers of staff not being represented. I am told that ‘Accredited Training Departments’ already exist. As a senior member of a Medical Engineering Department I have no knowledge of what this means and how this would affect training of staff within my own department - one of the biggest in the UK! Any process must be transparent and inclusive to ensure that the process goes through smoothly and has no detrimental effect on the sourcing and supply of qualified staff which is already very difficult.

Main questions

See 1.2

 

6. Representation of Unions and Other Professional Organisations

It is vital that all unions and other professional organisations such as the IEE representing the staff involved are consulted and a part of the process. State Registration is likely to have a major impact on staff training development, work and employment practices etc. It would be unthinkable to bring in some knew form of State Registration for nurses without consulting the major nursing organisations or unions!

Main questions

See 2.2

Finally

My personal view is that many of these questions need clear answers and resolving before the process of ‘State Registration for Clinical Technologists’ can be considered and progressed further. I would me most grateful for complete and comprehensive answers to be given as the implications of ‘State Registration for Clinical Technologists’ as described on the IPEM web site will have a major impact on the provision of equipment management services and staff throughout the NHS.

K.R. Haylett, PhD, MIEE, C.Eng

  

10.5          Results of IPEM Voluntary Register of Clinical Technologists (VRCT)

FROM IPEM web site

The VRCT Ballot

Following the ballot of Registrants held in February 2004, each Registrant

was asked to vote on the following proposal:

The Assessors’ Panel of the Voluntary Register of Clinical

Technologists propose that an application be submitted to the

Health Professions Council requesting that the Clinical

Technologist profession be regulated by the Health

Professions Council. Do you agree with this proposal? – Vote

YES or NO.

The following results were announced by the independent scrutineers on 2

March 2004:

Number of ballots distributed: 1477

Number of ballots returned: 775 (100%) – A return of 51%.

Number of YES votes returned: 722 (93%)

Number of NO votes returned: 53 (7%)

As a consequence of the vote the Assessors’ Panel of the Voluntary Register

of Clinical Technologists will now take forward, at the earliest opportunity, an

application for regulation by the Health Professions Council.

JY Methven

Registrar

4 March 2004

 

 

Updated - 04/02/2005